The conference will begin shortly. Welcome to the third quarter 2022 earnings conference call for Organogenesis Holdings Inc. At this time, all participants have been placed in listen-only mode. Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly. Before we begin, I would like to remind everyone that our remarks today may contain forward-looking statements that are based on the current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including the risks and uncertainties described in the company's filings with the Securities and Exchange Commission, including Item 1A, Risk Factors, of the company's most recent annual report and its subsequently filed quarterly reports.
You are cautioned not to place undue reliance upon any forward-looking statements which speak only as of the date made. Although it may voluntarily do so from time to time, the company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. This call will also include references to certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliations of those non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the investor relations portion of our website. I would now like to turn the call over to Mr. Gary S. Gillheeney, Sr.
Gillheeney, Sr., Organogenesis Holdings President and Chief Executive Officer. Please go ahead, sir.
Thank you, operator, and welcome everyone to Organogenesis Holdings third quarter 2022 earnings conference call. I'm joined on the call today by David C. Francisco, our Chief Financial Officer. Let me start with a brief agenda of what we will cover during our prepared remarks. I'll start with a high-level review of our third quarter revenue results and some recent operating highlights. After my opening remarks, David will provide you with a more in-depth review of our third quarter financial results, our balance sheet and financial position at the end of the third quarter, and the guidance for 2022 that we updated in today's press release, and then I will open it up for questions.
Beginning with the review of the third quarter, we reported net revenue of $116.9 million, an increase of 3% year-over-year, driven by a 2% increase in sales of our advanced wound care products and a 15% increase in the sales of our surgical and sports medicine products. Third quarter sales results came in below the guidance range we provided on our second quarter call, driven primarily by softer than expected growth in our advanced wound care products, while sales of our surgical and sports medicine products were roughly in line with our prior expectations. We believe that Hurricane Ian impacted demand in Florida in the last week of the quarter. We estimate that excluding this hurricane-related business disruption, we would have delivered advanced wound care sales results within the lower end of our third quarter guidance range.
As expected, we experienced continued improvement in COVID-related headwinds as patient visits improved in quarter three. Customers are continuing to struggle with staffing challenges, particularly customers in the physician office setting. While we were pleased to see these headwinds show measured improvement, we experienced a more challenging operating environment in the physician office setting versus what we had assumed in our previous guidance. Importantly, despite unexpected challenges in the quarter, the team performed well as we continue to execute against our growth strategy and leverage our competitive positioning, including the strength of our expanded sales force, the benefits of our comprehensive portfolio and leveraging multiple sales channels and new product introduction, including our brand loyalty. Let me update you on the progress of each of these in Q3.
First, our commercial team has grown to 365 direct representatives, up 11% year-over-year, and we believe our commercial team continues to represent a key competitive advantage for Organogenesis. The strength of our sales force enables continued expansion across the country and deeper penetration as our team increases awareness of the benefits of our advanced technologies. Second, we continue to make progress in diversifying our revenue across physician specialties and sites of care by targeting our product development and commercial strategies to drive growth in these key channels. Excluding ReNu, NuCel and Dermagraft, the team delivered low double-digit growth in number of accounts served in both the hospital outpatient setting and the physician office setting compared to the prior year. Third, our broad and highly differentiated portfolio of products continues to be a key advantage for the company.
Sales of our PuraPly products increased 12% year-over-year. A long-term strategy to introduce new products and line extensions have enabled access to multiple sites of care, including new physician specialties, and continue to drive strong demand for this well-established, highly differentiated PuraPly brand. Our portfolio of PuraPly technologies expanded in Q3 as we received 510(k) clearance for PuraPly MZ, representing a continuation of brand extension strategy of the PuraPly product portfolio. PuraPly MZ leverages the innovative properties of our PuraPly technology engineered into a micronized or powdered form to provide surgeons with an option for complex surgical wounds. We expect PuraPly MZ to be a material driver of growth in our surgical and sports medicine product grouping when it enters the full market in Q1 of 2023.
While we were pleased to see continued strong adoption and utilization of our PuraPly product, sales of our non-PuraPly portfolio of products declined 6% year-over-year in Q3. The decline in non-PuraPly products was driven by a 21% decline in net revenue from our PMA and other products, offset partially by a 2% increase in the sales of amniotic products compared to the prior year. The year-over-year decline in PMA and other sales was directly related to the prior year comparison, which included Dermagraft sales, which were suspended in the second quarter of 2022. PMA and other sales increased mid-single digits excluding the impact of Dermagraft in the period. Sales of amniotic products increased low single digits versus our expectation for low double-digit growth year-over-year in Q3.
While sales of our amniotic products increased on both a year-over-year basis and a quarter-over-quarter basis in Q3, our amniotic sales results were impacted by continued competitive pressure in the office channel, which challenged our share of voice in slowed adoption of our amniotic technologies with new customers. We also continued to see impacts on existing custom demand as a result of aggressive pricing strategies from smaller amniotic players, leveraging the lack of CMS published ASPs for the skin substitute products. Despite this more challenging environment for our amniotic products in the office channel, we successfully leveraged our diverse portfolio and drove strong growth of our PuraPly brand again in Q3. Simply stated, we are navigating in unexpected challenges in one of our key markets considering the circumstances.
We have developed and delivered year-over-year growth in sales of our advanced wound care products during the first nine months of 2022, fueled by our team's success in leveraging our diversified portfolio of products, including impressive growth from our PuraPly brand, where sales have increased 37% year-over-year for the first nine months of 2022. While our revenue growth has been paced by unexpected headwinds this year, we have expanded the number of accounts using our products over the first nine months of 2022 in both the HOPD and physician office setting, which speaks to the success in executing against one of our key long-term growth strategies.
We've updated our full year 2022 guidance, which now calls for net revenue in the range of $448 million-$465 million, which at the midpoint represents a decline of approximately 2% year-over-year on a reported basis and essentially flat year-over-year on an adjusted basis. Our full year 2022 revenue guidance now reflects a more challenging operating environment in the physician office setting in the fourth quarter compared to what our prior guidance had assumed. Specifically, we expect the sales in the physician office setting to be impacted by continuing competitive pressure from smaller amniotic players and overall market disruption driven by reimbursement uncertainty related to CMS's publishing of ASPs for skin substitute products this year. Importantly, we believe this competitive pressure from amniotic players will continue until CMS moves forward with publishing ASPs.
That said, we continue to believe that we are well positioned with our unique customer value proposition, offering a broad portfolio of products across the continuum of wound care, diversified revenue sources across multiple sites of care and physician specialties, and our broad commercial reach. While the office channel is facing challenges this year, we continue to grow our customer base and build on our leadership position in the office setting, as well as in wound care centers across the United States. Long term, we will continue to be a leader in the advanced wound care space by launching highly innovative, highly efficacious products as we deliver on our mission to provide integrated healing solutions that substantially improve outcomes while lowering the overall cost of care. Before I turn the call over to David, I wanted to provide you two operational items of note.
First, as disclosed in our 10-Q filing with the SEC this evening, the company decided to pause the construction of one of our Canton, Massachusetts manufacturing facilities. The decision was made in response to the material increase in the expected investment for this facility due to the inflation in materials and construction costs in recent years. Specifically, the latest estimated project total investment represented a 40% increase from the original budget that we established two years ago. We simply cannot justify allocating capital to this endeavor given the material change in required investment. We are currently evaluating potential alternatives and will provide updates as key decisions regarding alternatives are made going forward.
It's important to note that the decision to pause the construction of this manufacturing facility will not impact our ability to meet our market's demand for our existing commercialized products or our ability to achieve our target of greater than 80% gross margins in the future. Second, we continue to make progress during the third quarter in our ongoing phase III clinical trial for ReNu for the treatment of knee osteoarthritis. Our clinical team has enrolled more than 82% of the patients needed for the trial, has activated 7 additional investigational sites, as well as implementing additional recruitment strategies to further accelerate the pace of enrollment over the balance of 2022. We continue to target the completion of enrollment by the end of the year.
We also remain on track to complete the first interim analysis of data for 50% of the subjects in late Q4. We are also planning to submit an IND amendment to the FDA and expect to be ready to launch a second Phase III trial by the end of the second quarter of 2023. We have determined that at this stage, it's the best approach from a timing and regulatory perspective is to submit the IND amendment and moving forward immediately as it allows the company to initiate a second Phase III study as soon as possible and leverage the major operational advantages we have of continuing with the current active investigator sites. This plan essentially gives us more options in our regulatory approach.
This is based on our strategy of presenting to the FDA the completed 200-patient randomized controlled trial and the current phase three trial as valid scientific evidence of ReNu's safety and efficacy for knee osteoarthritis, and thus why the second FDA trial, a phase three study, should not be required. Finally, I want to share a few thoughts on the announcement from CMS on November second regarding the proposed changes for Medicare payments under the physician fee schedule for advanced wound care treatment. By way of reminder, CMS issued proposed rule in July, which represent a first step to standardize reimbursement for all types of wound care delivered in the physician office, including cellular and tissue-based products.
Based on the feedback received during the open comment period, CMS decided it would be beneficial to provide interested parties more opportunity to comment on the specific details of changes in coding and payment mechanisms prior to finalizing a specific date when the transition to a more appropriate and consistent payment and coding for these products will be completed. CMS is conducting a town hall in early 2023, and we look forward to participating in this event as well as continuing our engagement with them on this important initiative. Now with that, let me turn the call over to David for a review of our financial results in the third quarter, our balance sheet and financial condition as of the end of the quarter, and review of our 2022 financial guidance that we updated in today's press release. David?
Thank you, Gary. I'll begin with a review of our third quarter financial results. Unless otherwise specified, all growth rates referenced during my prepared remarks are on a year-over-year basis. Net revenue for the third quarter of 2022 was $116.9 million, up 3%. Our advanced wound care net revenue for the third quarter of 2022 was $109.5 million, up 2% year-over-year. Net revenue from surgical and sports medicine products for the third quarter of 2022 was $7.3 million, up 15%. Net revenue from our PuraPly products for the third quarter of 2022 was $63.7 million, up 12%.
Gross profit for the third quarter of 2022 was $90.7 million, or approximately 77.6% of net revenue, compared to 77% last year. The change in gross margin compared to the prior year was driven primarily by changes in product mix. Operating expenses for the third quarter of 2022 were $88.9 million, compared to $71.3 million last year, an increase of $17.6 million or 25%. The increase in operating expenses in the third quarter of 2022 was driven by a $17 million or 27% increase in selling general administrative expenses and a $0.6 million or 7% increase in research and development costs compared to the prior year.
The year-over-year increase in selling general administrative expense was primarily due to additional headcount, primarily in our direct sales force, and higher spending in travel and marketing programs amid relaxed COVID-19 travel restrictions. The year-over-year increase in R&D was driven by a step-up in clinical study spend and related costs necessary to seek regulatory approvals for certain of our products. Third quarter 2022 GAAP operating expenses included certain non-operating items. There was a $4.2 million charge related to the disposal of certain equipment related to the construction in progress in one of the company's Canton, Massachusetts facilities. $0.6 million of cancellation fees incurred in connection with the company's decision to pause its manufacturing facility construction project, and $0.6 million of employee retention and benefits, as well as other exit costs associated with the company's restructuring activities.
This compares to certain non-operating items totaling $1.2 million in the prior year period. Excluding these non-operating items and non-cash intangible amortization of $1.2 million and fair value of contingent consideration of $0.9 million in the prior year period, non-GAAP operating expenses for the third quarter of 2022 increased 19% year-over-year. Note, we have a detailed reconciliation of these non-operating and non-cash items in our press release this afternoon. Operating income for the third quarter of 2022 was $1.8 million, compared to operating income of $16.3 million last year, a decrease of $14.5 million.
Total other expenses for the third quarter were $0.6 million, compared to $3.4 million last year, a decrease of $2.8 million or 83%, driven primarily by the prior year period, including a $1.9 million of loss on extinguishment of debt, which did not impact the financial results in the third quarter of 2022. The remaining year-over-year decline in total other expenses in the third quarter of 2022 is attributable to reduced interest rate for borrowings under the new credit agreement signed in August of 2021. Net income for the third quarter of 2022 was $0.2 million compared to income of $12.6 million last year, a decrease of $12.4 million.
Adjusted EBITDA of $11.6 million for the third quarter of 2022 or 10% of net revenue compared to adjusted EBITDA of $21.7 million or 19% of net revenue last year. We have provided a full reconciliation of our adjusted EBITDA results in our earnings press release issued this afternoon. Turning to the balance sheet, as of September 30, 2022, the company had $108 million in cash and cash equivalents and restricted cash, and $72.6 million in total debt obligations, compared to $114.5 million in cash and cash equivalents and restricted cash, and $73.6 million in total debt obligations, of which $0.2 million were capital lease obligations as of December 31, 2021.
As a reminder, we also have up to $125 million of available borrowings on our revolver credit facility as of September 30, 2022. Turning to a review of our 2022 net revenue guidance, which we updated in our press release this afternoon. For 12 months ending December 31, 2022, the company now expects net revenue between $448 million and $465 million, representing a decrease of approximately 1%- 4% year-over-year and roughly flat on an adjusted basis, excluding sales of ReNu and NuCel for the first 5 months of 2021. The 2022 net revenue guidance range now assumes net revenue from advanced wound care products is flat to down 2% year-over-year.
Net revenue from surgical and sports medicine products decreased approximately 11%-25% year over year, and net revenue from sale of our PuraPly products increases approximately 27%-31% year over year. By way of reminder, our 2021 results include approximately $11 million in revenue attributable to ReNu and NuCel products during the five months ended May 31, 2021, the end of the FDA enforcement grace period. Excluding sales of these ReNu and NuCel for the first five months of 2021, our 2022 revenue guidance implies roughly flat growth year over year on an adjusted basis. In terms of profitability guidance for 2022, the company now expects to generate GAAP net income between $12 million and $20 million, adjusted net income between $22 million and $31 million.
We also expect EBITDA of between $31 million and $42 million and adjusted EBITDA between $46 million and $58 million. In addition to our formal financial guidance for 2022, we're providing some consideration for modeling purposes. Our full year 2022 guidance range now assumes sales of our amniotic products will decrease at the midpoint of our full year net revenue range of approximately 28% year-over-year in 2022, compared to prior guidance, which assumed a decline of approximately 15% year-over-year. Sales of our non-PuraPly non-amniotic products, which collectively form the group called PMA and other, will decrease at the midpoint of the range approximately 19% year-over-year in 2022, compared to our prior guidance, which assumed a decrease of 17% year-over-year. Gross margins of approximately 76.5%-77%.
Total GAAP operating expenses will increase approximately 15%-16% year-over-year as compared to our prior expectation of growth in the range of 13%-16% year-over-year, which includes the non-operating charges of $4.8 million related to the 275 Dan Road project. Total interest and other expenses approximately $2.8 million compared to $3.5 million previously, and a GAAP tax rate of approximately 30% compared to 27% previously. Non-cash D&A and non-cash stock comp expense of approximately $11 million and $6 million respectively, with a weighted average diluted share count of approximately 132 million shares. We now expect full year 2022 CapEx to be approximately $30-$35 million compared to $50-$60 million previously. With that, operator, I'll turn the call back over to you.
Thank you, sir. If you'd like to ask a question, please signal by pressing star one one on your telephone keypad. If you're using a speakerphone, please be sure that your mute function is turned off to allow your signal to reach our equipment. We do ask that you limit yourself to one question and one follow-up. Then if you would like to ask additional questions, we invite you to add yourself to the queue again by pressing star one one. Our first question is from Steve Lichtman with Oppenheimer. Steve?
Thank you. Hi, guys. I was wondering, Gary, if you could talk to, you know, what within the amnion business perhaps got worse from the second quarter call or didn't get better as you would have expected at that time. Maybe you could drill down a little bit more specifically on that. Sure. I think the competitive pressure that we talked about in Q2 has continued. You know, without the publishing of ASPs for all of the products that are out there is, you know, a lot of aggressive pricing and rebating and discounting that continues. You know, we see that consistent, maybe slightly a little bit higher, but we also see more confusion in the market with reimbursement.
You know, with the Physician Fee Schedule coming out, there's a lot of confusion, particularly in the office setting, where they don't necessarily have, you know, sophisticated reimbursement support in that setting and understanding what it means, as well as the, you know, non-published ASP issue. A lot of noise, a lot of confusion and, you know, disturbance that we don't see clearing up, and certainly didn't project that would be the case, you know, until CMS publishes these ASPs and brings clarity, obviously, to Physician Fee Schedule, or at least that clarity is being is able to be delivered to the office space so they understand exactly what's happening.
Okay. I guess just as a follow-up on new products, you mentioned on the PuraPly side, but I don't think you mentioned anything on NovaChor. Any update there? Does the change in your thoughts on the facility expansion impact TransCyte at all, or is that separate?
On NovaChor, we had a soft launch, and that product is being launched right now. As we've guided, we didn't expect that it would have a significant impact in this last quarter. We expect that it'll have more of an impact certainly next year. The clinical results that we're getting from the field are very strong. You know, the handling is a little different, a little better. You know, clinicians really appreciate the product. Regarding TransCyte, you're correct. Our TransCyte and Dermagraft were both scheduled to be manufactured in our new facility. We do have alternatives that we're looking at, and you know, we'll update you when those alternatives are actually coming forward.
We do have some additional alternative strategies, in particular to get those products out on the market.
Okay. I'll leave it at the two and jump back in queue. Thanks.
Thank you, Steve.
Thank you very much. Our next question will be from Ryan Zimmerman with BTIG. Ryan?
Yeah, thank you. Can you hear me okay?
Yes, Ryan, we can.
Hey, good afternoon. Thanks for taking the questions.
Of course.
Gary, wanna follow up on a couple things. You cited a lot of factors, you know, this quarter, be it, you know, hurricane impact in the office, staffing, et cetera. I don't know if you could kinda parse out or not, you know, how the magnitude of each and how to think about each of those factors, as we move into fourth quarter. I mean, I can appreciate that competition is not abating as you had expected previously, but, you know, and this is kind of a multi-part question, Gary, but what's your expectation for when that does abate? Then I have a couple follow-ups.
Yeah. I mean, the hurricane is, you know, situational. It just happened and just affected our last, you know, week of sales as folks started to shut down a little bit before it hit. Then the last day, we had some challenges getting product out down into the Florida area. You know, that certainly affected our ability to jump into the range, the guidance range, but we were still gonna be at the lower end of the range. That speaks more to the, you know, reimbursement confusion as well as the competitive pressure, as you mentioned. When does the competitive pressure end?
You know, I think us and others feel clearly publishing everyone's ASP is the first step and a major step of just leveling the playing field and allowing that competitive pressure on pricing and rebating to end. That's important. You know, once there's clarity, I think, in CMS's Physician Fee Schedule ruling and how those changes are gonna take place and how it will be calculated, all the questions we've all asked, I think, you know, that overhang will kind of lift. You know, our feeling, as I've said before, is, you know, we see that the delay in the CMS filing, you know, is a good thing, that they're looking for more input.
They're looking for, you know, industry's input as well as clinical input to what's the right strategy here to make sure patients still have access to that site of care and all of the products that those patients need. You know, we think that will help significantly as well in the competitive area with a reasonable result in the office and do extremely well at site, and we'll continue to add share with a reasonable change in that site of care.
Okay. Couple follow-ups for me, if I could, though. Just to be clear, I think CMS published the rate for Affinity in the fourth quarter down 12%. I just wanna make sure that that's correct. You know, is that also more of a near-term impact and kinda how do you expect that to follow as we move into 2023?
Yeah. I mean, we don't talk about the pricing strategy going forward, but I mean, it definitely was down. We did take the price down, and part of that is related to this, you know, intense pricing competition that we're experiencing right now. The commercial team is very focused on ensuring that they understand what's happening in each of these accounts and doing everything they can to combat the situation that we're in right now. You know, I mean, the fundamentals are strong still in the business. You know, I think the fact is the, you know, commercial team is, as you know, quite broad, and, you know, we'll continue to push that forward. We continue to build out, you know, our customer base, and so they're doing a great job from that standpoint.
It's just not growing as fast as we would like, you know.
Okay.
Clearly, under the new guide, you know, excluding ReNu and NuCel and, you know, Dermagraft, really getting down to our core, we're still, you know, growing modestly. So, you know, we feel good about the foundation and fundamentals of the business.
I don't know if you wanna comment right now on 2023, guys. I mean, I know it's early, but, you know, what is your expectation for just the overall growth rate of the business, be it Advanced Wound Care or Surgical and Sports Medicine, as we think about 2023 and some of the puts and takes that may, you know, that we should be considering, in the context of all these, you know, dynamics?
Well, as David said, we don't really talk about 2023, but, you know, some of the dynamics, Ryan, I mean, the way we look at it, we certainly will have a much bigger sales force. You know, we have a lot of new reps that we've added at the end of the year that will help, you know, drive that customer growth that we've already seen even this year with the headwinds. We do have new products, as you mentioned, that will have more of an impact in 2023. PuraPly brand is doing extremely well, you know, in the surgical setting. That's an area that we focus on, and we're adding a lot of accounts. We've added, you know, double-digit growth in accounts that will be available to us next year with that larger sales force.
As David said, the fundamentals of the base business, the core business is good. You know, what happens going forward, you know, we'll have to assess when we get more information on the competitive environment, CMS' decisions.
Yeah, agree.
Just last one for me, and I'll hop back in queue. As we think about cost next year, Dave, you know, I know there were some one-time dynamics this quarter that lifted up OpEx, but assuming that comes back out, you know, how do you kind of expect to manage cost in the next year? Do you feel like you need to belt-tighten? Just, you know, you're scaling back, obviously, the facility in Massachusetts. Is there any other belt-tightening that you consider to allow you to kind of keep up some of those margins?
Yeah. Ryan, it's a great question. I mean, obviously, as Gary said, we're not ready to talk about 2023 yet, but we have made a lot of investment in 2022. As you said, there's some, you know, kind of transitory costs in there that are not gonna repeat. But you know, we will obviously be prudent in our investment profile based on, you know, what the outlook is for revenue. You know, we're really, as we both said, you know, the fundamentals of the business are still here. They're strong. Again, we're continuing to build the customer base. We wanna make sure that we have the resources and the infrastructure to capture that demand when it returns at a stronger basis than it is today.
Thanks, guys.
Thanks, Ryan.
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